Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop (ACTIVE Health)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00076141
First received: January 14, 2004
Last updated: December 12, 2013
Last verified: December 2013

January 14, 2004
December 12, 2013
January 2002
January 2014   (final data collection date for primary outcome measure)
To determine whether differences in the prevalence of common chronic conditions affecting older veterans among African-American and white male veterans are explained by medical, lifestyle, dietary, or other risk factors. [ Time Frame: Every six months for at least five years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00076141 on ClinicalTrials.gov Archive Site
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Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop
CSP #499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT

The purpose of this study is to gather a mixed racial group of relatively healthy male veterans (for example, White, African-American, and Hispanic), who are at least 50 years of age. These men will be followed to see what types of diseases they develop and to determine if racial differences in lifestyle, blood test results, or genes are related to the types of diseases that are found. Diseases of particular interest are prostate cancer, other cancers, cardiovascular disease (for example, heart attacks and stroke), high blood pressure and diabetes. The group to be followed will consist of about 16,000 men recruited from about 40 VA Medical Centers across the country. Each man will be followed for at least five years depending on when he enters the study.

The purpose of this study is to gather a mixed racial group of relatively healthy male veterans (for example, White, African-American, and Hispanic), who are at least 50 years of age. These men will be followed to see what types of diseases they develop and to determine if racial differences in lifestyle, blood test results, or genes are related to the types of diseases that are found. Diseases of particular interest are prostate cancer, other cancers, cardiovascular disease (for example, heart attacks and stroke), high blood pressure and diabetes. The group to be followed will consist of about 16,000 men recruited from about 40 VA Medical Centers across the country. Each man will be followed for at least five years depending on when he enters the study.

Participants are asked to complete a set of forms to provide a brief medical history, demographics, information on lifestyle such as physical activities, smoking, and drinking, information on diet, and information on quality of life.

Subjects will be seen on a biannual basis with follow-up telephone interviews conducted during the intervening years. Follow-up telephone interviews will be conducted at the MAVERIC Call Center while follow-up clinic visits will take place at each SELECT site. In addition, VA clinical and administrative databases will be used to augment follow-up and confirm reported events.

During follow-up visits, participants will be asked whether they experienced any medical events since the last study visit, with information on specific diagnoses including prostate cancer, lung cancer, colon cancer, other cancers, stroke, myocardial infarction, hypertension, diabetes mellitus, kidney disease, chronic prostatitis, and benign prostatic hypertrophy. Confirmation of self-reported diagnosis will be made by an examination of discharge summaries, medical records, and available diagnostic and laboratory information by an end-points committee.

Recruitment for this observational cohort will proceed in parallel with recruitment for SELECT and can use SELECT staff and resources with very little additional burden in cost or staff time.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

PE and buffy coat

Non-Probability Sample
  • relatively healthy male veterans
  • at least 50 years old
Healthy
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Group 1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
991
January 2016
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • relatively healthy male veterans
  • at least 50 years old

Exclusion Criteria:

  • Life expectancy of at least 5 yrs
Male
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00076141
499A
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Study Chair: Michael J. Gaziano, MD MOH VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Department of Veterans Affairs
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP